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NOT YET RECRUITING
NCT07481032
NA

Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\_yu syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1034

Start Date

2026-04-01

Completion Date

2028-11-30

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Biejia-Ruangan compound

receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy

DRUG

Biejia-Ruangan compound simulant

receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy